Identity
- Trade Name
- Převodová souprava PS M EUDAMED
- Device Name
- Převodová souprava EUDAMED
- Model / Reference
- V606386-02M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540513885 EUDAMED
- Basic UDI-DI
- 85935406TF07PREVODOVERG EUDAMED
- EMDN Code
- A03040202 OCULAR IRRIGATION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Převodová souprava PS M by GAMA GROUP a.s. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85935406TF07PREVODOVERG | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 9466eeb5-a148-4b0f-a089-92ccdb615b54 61 fields · synced Jul 14, 2026